Medtronic is recalling almost 40,000 batteries for its HeartWare Ventricular Assist Device (HVAD) system because of performance issues, continuing the product safety problems for the heart pump.
The Food and Drug Administration labeled the recall a Class I event, the agency’s severest classification. This is Medtronic’s third Class I recall for the system in 2022 even though the company stopped selling the device in June 2021 for safety concerns.
The batteries were recalled because of electrical faults that make them unable to power the system’s control, accept a charge from the battery charger and/or appear to remain charged while discharging, according to the FDA’s Aug. 18 database entry.
Medtronic sent a notice to HVAD coordinators in late June asking them to remind patients to keep two sources of power connected to their controller, have fully charged spare batteries available at all times, acknowledge and report alarms, follow instructions for power source management and to “be vigilant” if battery indicator lights do not decrease while the battery is being used, the FDA said.
The recall was initiated on June 28 and affects 39,640 batteries distributed globally. Medtronic began a separate recall for HVAD batteries on May 5, although it only affected 429 units. The recall was tied to one patient death, and the FDA labeled it a Class I event.
Medtronic recalled pump implant kits in April because of welding defects in certain devices that could allow moisture to enter and cause the corrosion and demagnetization of internal magnets, which can cause the pumps to rotate incorrectly.
The recall, also a Class I event, was tied to one death and two injuries, according to an emailed statement in June from the company.
Medtronic didn’t provide a statement regarding its latest HVAD recall by publication.
The HVAD system, which is used to circulate blood for patients with heart failure, has a history of product safety problems tied to reports of device malfunctions, injuries and deaths. After three Class I recalls at the beginning of 2021, Medtronic pulled the system off the market and coordinated with Abbott Laboratories to ensure that patients who needed a similar device had options.
The system has racked up more than a dozen Class I recalls since being approved to be on the market in late 2012, some while Medtronic owned the system and some before the company bought HeartWare International for $1.1 billion in 2016.
Thousands of patients still had devices implanted when Medtronic stopped selling the system. The company has maintained that removing the device is riskier for patients than continuing to use it.
As of June, there were approximately 3,500 patients who still had the system implanted, according to Medtronic.